CN106822762A - The rheumatism 25-component ball and its preparation technology of a kind of steady quality - Google Patents

The rheumatism 25-component ball and its preparation technology of a kind of steady quality Download PDF

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Publication number
CN106822762A
CN106822762A CN201710201870.9A CN201710201870A CN106822762A CN 106822762 A CN106822762 A CN 106822762A CN 201710201870 A CN201710201870 A CN 201710201870A CN 106822762 A CN106822762 A CN 106822762A
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rheumatism
pill
water
ball
component ball
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CN106822762B (en
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陈金小
王锦华
王嘉铎
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ULANHOT ZHONGMENG PHARMACEUTICAL CO Ltd
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ULANHOT ZHONGMENG PHARMACEUTICAL CO Ltd
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    • A—HUMAN NECESSITIES
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    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37—Digestive system
    • A61K35/413—Gall bladder; Bile
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
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    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/55—Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract

The invention discloses a kind of Mongolia patent drug rheumatism 25-component ball of steady quality, the preparation technology of rheumatism 25-component ball is especially disclosed.The rheumatism 25-component ball that the present invention is provided, its quality of the pharmaceutical preparations stabilization, can at utmost ensure that the active ingredient of preparation is absorbed by organisms at the appointed time.The effects such as there is qi-regulating, the scattered stasis of blood for arthritis, rheumatoid, trip pain etc..The preparation technology of the rheumatism 25-component ball that the present invention is provided, the technique makes final product quality stabilization, leach the time limit suitable, especially technique is on the basis of without original prescription is changed, by rationally control process conditions, preferable processing quality index is obtained, the stability and security of product are also fully consistent with the relevant regulations of pharmacopeia.

Description

The rheumatism 25-component ball and its preparation technology of a kind of steady quality
Technical field
The present invention relates to a kind of pharmaceutical preparation, and in particular to a kind of anaesthetic pill and its preparation technology.
Background technology
Mongolia Medicine has the history of more than 2000 years, and it is the indivisible important component of Chinese traditional medicine.At present In China's anaesthetic industry development, there is more than 200 kinds of Mongolia patent drug preparation to take in national standard, but anaesthetic typical problem still compared with It is protrusion, the quality standard problem of anaesthetic material and prescribed preparation not only affects the performance of anaesthetic effect, while also contributing to cover The process of medicine industrialization.Anaesthetic material is to check anaesthetic material, the foundation of Mongolian medicinal preparation quality with anaesthetic patent medicine quality standard, and anaesthetic The quality and curative effect of patent medicine have close with crude drug source, prescription feature, anaesthetic theory, Preparation process, process route etc. again Relation.
" Mongolia patent drug-water pill quality investigation " of anaesthetic the article pointed out the preparation method of Mongolia patent drug water pill be by Each taste anaesthetic material in prescription is ground into certain fineness, makees wetting agent with water after being well mixed, by some compositions in medicinal material As sugar, starch, mucilaginous substance, glue class etc. produce adhesive effect, make that medicinal material powder is general to be made type, be drying to obtain.It is generally acknowledged that water is general Ball easily disperses, but from terms of measurement result, and it is unqualified that Ershiwuwei zhenzhu wan, 25-component coral ball leach the time, the two product Plant water content and be less than other kinds.Illustrating that anaesthetic patent medicine water pill water content is low causes pill close structure, moisture to be difficult to ooze Enter and make to leach time lengthening.
The article pointed out that the water-bindered pill refers to fine drug powder in " solving the problems, such as that the water-bindered pill leaches the discussion of time limit method " of Zhao Jiaxiang It is the pellet shapes pill that binder is made with cold boiling water, concoction, yellow rice wine, liquid glucose or other liquid, is one of Chinese medicine conventional dosage forms, Due to general ball pill small volume, surface is smooth, convenient to take, is easy to many advantages, such as preserving, and is still widely used at present, but water Ball is primary medicinal powder directly general ball, due to being influenceed by many factors in preparation process, often occur leaching the time limit is unqualified and shadow The quality of Xiangshui County's ball and application.And it is further believed that the medicinal material of congruent melting of being heated, the speed of general ball and water consumption, water-bindered pill water content, The temperature and time of drying, using ethanol, prepared slices of Chinese crude drugs pre-treatment, add disintegrant etc. be influence the water-bindered pill dissolve the time limit because Element.
Pointed out in " Chinese kmedicine bolus leach the discussion in time limit and product inherent quality " of Chen Xinfang, Chinese kmedicine bolus are Chinese medicine The conventional dosage forms of preparation, the composition of water-bindered pill weight is mostly vegetalitas powder, and active ingredient major part is wrapped in powder By leaching and then medicine spreads in intestines and stomach, dissolution, inhaled after that not yet breaks up is intracellular, therefore Chinese kmedicine bolus are oral Receive.Playing curative effect must control to leach the time limit.
Although the time limit that leaches to the water-bindered pill has enough knowledge, scholars leach the factor and solution in time limit to the influence water-bindered pill Certainly method gives beneficial guidance, but for producing the producer of the water-bindered pill, the water-bindered pill leaches duration and is still restriction Water-bindered pill factor of production, strictly controls technical indicator, and steady production product quality reduces the influence of enchancement factor, is solution Certainly unstable means of the water-bindered pill quality of the pharmaceutical preparations.
" rheumatism 25-component ball (fine jade element -25) " is written first recorded in 12nd century Tibetan medicine scholar Dagri Ma Gongbu《Record beautiful Decorations》, the most of Tibetanmedicine literature of ancient book come out after 12nd century are such as《Four doctor's allusion quotations》、《Lan Tabu》Deng and modern times 《Anaesthetic standard》Deng continuing to use and continuously record.With to cure mainly be dry " Xieri Wusu Symptom ", qi-regulating dissipates the stasis of blood to function, for swimming pain, Arthritis, rheumatoid.The product is the yellowish-brown water-bindered pill, gas micro-perfume, mildly bitter flavor.In the preparation by cow-bezoar, Moschus, west safflower difference Finely ground, and the medicinal material facing-up that remaining 22 taste is ground into fine powder, sieving is mixed, and with water pill, polishing, is drying to obtain.
Up to 25 kinds of the kind flavour of a drug, the factor being related in technical process and its various causes in existing process to technique Condition and indices carry out severe quality monitoring a larger difficulty, unstable product quality such as leach duration, effectively into Divide content unstable etc., the problem of technique governs the performance of the product greatest treatment efficacy.
The content of the invention
It is an object of the invention to provide a kind of rheumatism 25-component ball, said preparation steady quality can be protected at utmost The active ingredient for demonstrate,proving preparation is absorbed by organisms at the appointed time.
There is qi-regulating for arthritis, rheumatoid, trip pain etc. it is a further object of the present invention to provide one kind, the stasis of blood is dissipated The rheumatism 25-component ball of effect, can be such that user prevents within effective time after effective dose is taken, alleviates, improve And/or treat the illness.
The further object of the present invention is also resided in and provides a kind of preparation technology of rheumatism 25-component ball, and the technique makes finished product Steady quality, leaches the time limit suitable.
The prescription of rheumatism 25-component ball is as follows：
On part medicinal material used by the present invention：
Santal：It is the heartwood of sandalwood plants santal, contains volatilization eleoptene alcohol, terpene acid and terpenes etc..For trusted subordinate's pain, Heart heat, lung heat, outer painting disappear skin heat toxin.
Santal：Heartwood has fragrance, mildly bitter flavor.Containing volatile oil and santal pigment, deoxidation santal pigment etc..For qi-regulating, And stomach.
Moschus：Mainly contain moisture, ash content, oxygenatedchemicals, cholesterine, crude fibre, aliphatic acid and main active Muskone (2.2%), pungent-warm enters the heart, spleen, Liver Channel.Have one's ideas straightened out, invigorate blood circulation, dissipating bind, analgesic.
Cow-bezoar：Nitrogen acid, deoxycholic aicd, chenodesoxycholic acid and its esters.Cure mainly abscess of throat, aphthae, ulcer malignant boil Poison.
Kuh-seng：Containing various alkaloids, primary efficacy is heat-clearing and damp-drying drug, desinsection, diuresis.
Amomum cardamomum：Seed contains volatile oil, with dampness elimination promoting the circulation of qi, warming middle energizer to arrest vomiting, the effect of appetite-stimulating indigestion-relieving.
Resina liquidamberis：Containing volatile oil, with promoting blood circulation and stopping pain, solution taking poison and growing muscle due, cooling blood and hemostasis effect.
For the preparation technology of the water-bindered pill of the present invention：
In rheumatism 25-component ball of the invention, the flavour of a drug containing more grease type and gummy constituents, it makes the water-bindered pill Hydrophilic and hydrophobic be difficult to grasp, wetability reduction is met water and produces viscosity, and the thick substances of formation can cause hair during general ball Pore diminishes or blocks, and be an impediment to the water-bindered pill leaches the time.
By the resina liquidamberis low-temperature treatment containing resin and oil components in present invention process, after the resina liquidamberis after treatment is crushed Water absorption rate substantially increases, and viscosity diminishes, and be conducive to the water-bindered pill leaches the time.The low-temperature treatment can select less than 0 DEG C, excellent Less than -4 DEG C of choosing；Process time was with 5-15 hours, preferably 10-15 hours.
Donkey blood meal uses different particle diameters, the different blood meal of particle size to cause that the water-bindered pill is internally formed many and does not advise in prescription Capillary and hole then, moisture discharge suitable from inside to outside when these holes are conducive to pill to dry, the particle diameter of donkey blood meal 80-100 mesh particles account for more than the 50% of recipe quantity, and preferably 65-99%, further preferred 85-95%, preferable particle size are 100 mesh； Remaining blood meal particle diameter is 60-80 mesh, and preferable particle size is 65 mesh.
The grinding mode of medicinal material not only influence medicinal material particle size, while also influence herb in granule form between voidage, Inserted in batch (-type) filler mode and powder is carried out in pulverizer with kuh-seng medicine materical crude slice after first being crushed for santal of the invention, santal It is broken, fine powder after crushing again with other medicinal material mixing pills, water-bindered pill internal voids degree is obviously improved.
Technique of the invention, by rationally control process conditions, is obtained preferably on the basis of without original prescription is changed Leach the time limit.
For term of the invention：
Water pill, refers to the water-bindered pill, means that one or more traditional Chinese medicine fine powder selectivity plus suitable excipient are made spherical Preparation, the characteristics of it is lasting to be relaxed with effect, covers bad smell, and convenient to take.
Leach the time limit：Refer to take for the ball of formula product 6, (pill diameter is below 2.5mm's for the hanging basket of the appropriate aperture screen cloth of selection With the screen cloth of diameter about 0.42mm, the screen cloth of the use diameter 1.0mm between 2.5mm-3.5mm uses diameter in more than 3.5mm The screen cloth of about 2.0mm), according to the method (annex XIIA) under disintegration time limited inspection technique tablet plus baffle plate inspection.Except as otherwise rule Fixed outer, small honey pill, water-honeyed pill and the water-bindered pill should all be leached in 1 hour；Condensed pill and starched pill should all be leached in 2 hours, The time limit that leaches of micropill is judged by the regulation of affiliated pill type, when pill adhesion baffle plate hinders inspection such as in operating process, should It is another to take for the ball of formula product 6, baffle plate is not added with by regulation inspection, should all leach at the appointed time.
Specific embodiment：
Rheumatism 25-component ball of the invention carries out the proportioning of flavour of a drug according to following prescription：
In preparation technology, the improvement of technique is carried out to specific medicinal material.The leaching of anaesthetic pill, drug release process are not fully etc. It is same as Western medicine.The either water-bindered pill, honeyed bolus, or condensed pill contain part powder medicinal material, the wherein release of active ingredient, in ball On the basis of grain is leached, powder medicine must also be by stages such as infiltration, infiltration, dissolving, diffusions.Although it leaches drug release process and answers Miscellaneous, mechanism is unclear, it is apparent that closely related with pellet wettability of the surface, capillarity, expansion and solvation. The present invention by being freezed to resina liquidamberis after be ground into fine powder and use, and/or donkey blood meal is distributed and/or right using different-grain diameter The batch (-type) filler pulverizing processing mode of santal, santal and kuh-seng causes rheumatism 25-component ball of the invention without extra Addition excipient is such as in the case of disintegrant, is significantly improved by improving porosity inside the water-bindered pill, the property of water-bearing and dilatancy The stability for leaching, releasing the drug of rheumatism 25-component ball, has ensured the quality of medicine, and technique is provided for maximum plays drug effect Basis.
Prepare embodiment
Embodiment 1, rheumatism 25-component ball lab scale sample
[prescription] rheumatism 25-component ball carries out the proportioning of flavour of a drug according to following prescription：
[preparation method]
1st, calculus bovis factitius 14g, muscone 14g, west safflower 14g are weighed and grinds as fine powder that to be mixed into I stand-by respectively；Donkey blood meal Fine powder II is mixed into I after sieving stand-by；
Granularity is：The donkey blood meal for taking recipe quantity 5% crushed 65 mesh sieves, remaining 100 mesh sieve mixing adapted；
2nd, after taking resina liquidamberis 30g freezings 12 hours fine powder is ground into be well mixed with II as fine powder III is stand-by；
Granularity is：All by 80 mesh, wherein 100 mesh reach 96%.
3rd, crushing is inserted in batch (-type) filler mode after mixing with kuh-seng medicine materical crude slice 20g after santal 12g, santal 20g are broken Crushed in machine, after crushing again with cape jasmine 20g, Rhododendron molle 20g, tsaoko 14g, Amomum cardamomum 14g, Chinese violet 14g, myrobalan 14g, Fructus meliae toosendan 14g, Radix Rhapontici seu Radix Echinopsis flower 14g, gypsum 4g, fragrant plantain lily flower 14g, nutmeg 24g, semen abutili 30g, Cassia occidentalis 30g, common bombax flower Stamen 16g, kapok petal 16g, cloves 16g, bark of eucommia 16g medicinal materials co-grinding are IV stand-by；
4th, by III and IV fine powder facing-up, sieving is mixed, and with water pill, polishing is dried, obtained final product.
Embodiment 2：Test agent in rheumatism 25-component ball
[prescription] rheumatism 25-component ball carries out the proportioning of flavour of a drug according to following prescription：
[preparation method]
1st, calculus bovis factitius 0.14kg, muscone 0.14kg, west safflower 0.14kg are weighed grind respectively and treated for fine powder is mixed into I With；It is stand-by with I fine powder II to be mixed into after donkey blood meal 1kg sievings；
Granularity is：The donkey blood meal for taking recipe quantity 5% crushed 65 mesh sieves, remaining 100 mesh sieve mixing adapted
2nd, after taking resina liquidamberis 0.3kg freezings 12 hours fine powder is ground into be well mixed with II as fine powder III is stand-by；
Granularity is：All by 80 mesh, wherein 100 mesh reach 96%.
3rd, filled out in batch (-type) filler mode after mixing with kuh-seng medicine materical crude slice 0.2kg after santal 0.12kg, santal 0.2kg are broken Enter in pulverizer and crushed, after crushing again with cape jasmine 0.2kg Rhododendron molles 0.2kg, tsaoko 0.14kg Amomum cardamomums 0.14kg, pale reddish brown Chinese violet 0.14kg, myrobalan 0.14kg, Fructus meliae toosendan 0.14kg, Radix Rhapontici seu Radix Echinopsis flower 0.14kg, gypsum 0.04kg, fragrant plantain lily flower 0.14kg, Pork and beans Cool 0.24kg, semen abutili 0.3kg, Cassia occidentalis 0.3kg, kapok pistil 0.16kg, kapok petal 0.16kg, cloves 0.16kg, Du Secondary 0.16kg medicinal materials co-grinding is IV stand-by；
4th, by III and IV fine powder facing-up, sieving is mixed, and with water pill, polishing is dried, obtained final product.
Embodiment 3：Rheumatism 25-component ball amplifies production sample
[prescription] rheumatism 25-component ball carries out the proportioning of flavour of a drug according to following prescription：
[preparation method]
1st, calculus bovis factitius 7kg, muscone 7kg, west safflower 7kg are weighed and grinds as fine powder that to be mixed into I stand-by respectively；Donkey blood meal It is stand-by with I fine powder II to be mixed into after 50kg sievings；
Granularity is：The donkey blood meal for taking recipe quantity 0.05 crushed 65 mesh sieves, remaining 100 mesh sieve mixing adapted
2nd, after taking resina liquidamberis 15kg freezings 12 hours fine powder is ground into be well mixed with II as fine powder III is stand-by；
Granularity is：All by 80 mesh, wherein 100 mesh reach 96%.
3rd, powder is inserted in batch (-type) filler mode after mixing with kuh-seng medicine materical crude slice 10kg after santal 6kg, santal 10kg are broken Crushed in broken machine, after crushing again with cape jasmine 10kg, Rhododendron molle 10kg, tsaoko 7kg, Amomum cardamomum 7kg, Chinese violet 7kg, scold Sub- 7kg, Fructus meliae toosendan 7kg, Radix Rhapontici seu Radix Echinopsis flower 7kg, gypsum 2kg, fragrant plantain lily flower 7kg, nutmeg 12kg, semen abutili 15kg, Cassia occidentalis 15kg, Kapok pistil 8kg, kapok petal 8kg, cloves 8kg, bark of eucommia 8kg medicinal materials co-grinding are IV stand-by；
4th, by III and IV fine powder facing-up, sieving is mixed, and with water pill, polishing is dried, obtained final product.
Comparative example 1：Rheumatism 25-component ball lab scale sample (former technique preparation)
[prescription] rheumatism 25-component ball carries out the proportioning of flavour of a drug according to following prescription：
[preparation method]
Above 25-component, in addition to cow-bezoar, Moschus, west safflower, the taste of remaining donkey blood meal etc. 22 is ground into fine powder, by ox Huang, Moschus, west safflower difference are finely ground, and above-mentioned fine powder facing-up, and sieving is mixed, and with water pill, polishing, are drying to obtain.
Drug effect and quality stability test example
Test example one：Rheumatism 25-component ball difference preparing process quality index compares
Inspect the different batches water-bindered pill prepared with two kinds of techniques of comparative example 1 (former technique) and embodiment 1 (existing technique) by random samples, Its every technic index is tested and analyzed such as following table.
Table one：Two kinds of processing quality index situations of rheumatism 25-component
Result above shows：Technique of the invention is significantly reduced compared with traditional handicraft on the basis of drug effect is ensured The time limit is leached, while the content of Gardenoside there has also been substantially increase.This shows process modification of the invention for for rheumatism two The industrial production of ten five tastes provides strong technical support.
Test example two：Rheumatism 25-component ball Different Preparation stability test
1st, rheumatism 25-component ball accelerated stability test
Rheumatism 25-component pill thing stability study takes comparative example 1 (former using the method for accelerated stability test Technique) and embodiment 1 (existing technique) test sample, in 40 DEG C ± 2 DEG C of temperature, 6 are stored under the conditions of relative humidity 75% ± 5% Month.Refer to pharmaceutical preparation stability test according to Pharmacopoeia of People's Republic of China version (two) annex XIX C bulk drugs in 2010 Principle is led, stability high spot reviews project is detected.Sampled once respectively at 1st month, the 3rd month, the 6th the end of month, according to According to the quality standard of rheumatism 25-component ball to proterties, outward appearance, discriminating, moisture content, disintegration time limited (minute), the Gardenoside of the product (C17H24O10) content, microbial limit test.The table two that result sees below.
Table two：Different process accelerated stability test Indexs measure result
Result of the test shows：Former technique is also basicly stable through stability observing, subject matter be leach the time limit do not meet will Ask.Existing preparation technology its accelerated test store results under the conditions of extraordinary compared visible with 0 month：The standard compliant rule of indices Fixed, it is more stable particularly to leach the time limit, and drug effect is played after being taken beneficial to patient, and experiment proves that the process of producing product can be protected Card product quality is controllable, and product is safe and effective in Storage period.
2nd, rheumatism 25-component ball long-term stable experiment
The method that rheumatism 25-component pill thing stability study uses long-term stable experiment, different batches of Example 1 Secondary test sample (160926,160927,160928) 3 batches, in 25 DEG C ± 2 DEG C of temperature, the condition of relative humidity 60% ± 10% Lower storage 36 months.3rd month during testing, 6 months, 9 months, 12 months, 18 months, 24 months, 36 the end of month difference Sample once, according to Pharmacopoeia of People's Republic of China version (two) annex XIX C bulk drugs in 2010 and pharmaceutical preparation stability Test direction principle, stability high spot reviews project is detected.According to the quality standard of rheumatism 25-component ball to the product Proterties, outward appearance, discriminating, moisture content, disintegration time limited (minute), Gardenoside (C17H24O10) content, microbial limit test.
Its result compared visible with 0 month：160926th, 160927,160928 batches of products are in condition stored above and Storage period Place 6 months, product quality is without significant change.
To sum up think, the rheumatism 25-component ball of existing technique productions accelerates and long-term stable experiment result is proved, the product Quality is controllable, and in Storage period safely and effectively, longer-term stability test proceeds product.
Test example three：Rheumatism 25-component ball safety testing
1st, rheumatism 25-component ball animal acute toxicity test
1.1 give examination to test：Take healthy Kunming mouse 10,20 ± 2g of body weight, male and female half and half.Prepared with embodiment 1 25% rheumatism 25-component ball content suspension presses 0.5ml/10g gastric infusions, continuous 7 days observed and recorded mouse after administration Reaction and death condition.Result finds, without 1 animal dead in 7 days, it is impossible to measure median lethal dose.Press《Chinese medicine, crude drug Thing studies on acute toxicity technological guidance's principle》It is required that, carry out maximum dosage-feeding experiment.
1.2 maximum dosage-feedings are tested:Kunming kind healthy mice 40,20 ± 2g of body weight, male and female half and half.Made with embodiment 1 The rheumatism 25-component ball content suspension of standby 25% presses 0.5ml/10g gastric infusions, for every eight hours once, totally three times.Give Continuous 14 days observed and recorded mouse reaction and death condition after medicine.Result is found, after administration in 14 days, animal wool coloured light is slided, and is taken the photograph Food, drinking-water, defecation and activity are without exception, and none death.Cervical dislocation put to death, visually observe the heart, liver, brain, spleen, kidney, The important organs such as stomach, intestines, uterus, testis, change without exception.Result of the test calculates the mouse maximum dosage-feeding of a day 37.5g/kg (equivalent to crude drug 75g/kg).Calculated by adult 70kg body weight, adult is 0.086g/kg, i.e. mouse per consumption per day 436 times of the quite clinical adult's dosage of daily oral maximum dosage-feeding.
Limited by drug concentration and administered volume, median lethal dose cannot be measured to gastric infusion of mouse.Through most Big dosage is determined, and the daily oral maximum dosage-feeding of mouse is 37.5g/kg (equivalent to crude drug 75g/kg), is clinical recommendation 436 times of daily dosage of being grown up.Document report, according to the weight, mouse maximum dosage-feeding equivalent to 100 times of people's consumption with On it is then safer.Therefore rheumatism 25-component ball is taken by clinical recommended dose, toxic and side effect is small, is safe and reliable.
2nd, the rat chronic toxicity test data of rheumatism 25-component ball
This experiment takes Kunming kind healthy mice 60, and 20 ± 2g of body weight, male and female half and half are divided into three groups immediately.Observe wind Wet 25-component ball is acted on the long term toxicity of rat.Result shows that rheumatism 25-component ball 5g/kg.d is (every equivalent to adult 50 times of day quantity, equivalent to crude drug 10g), 2.5g/kg.d (equivalent to 25 times of daily quantity of being grown up, equivalent to Crude drug 5g), 1.25g/kg.d (equivalent to 12.5 times of the daily quantity of being grown up, equivalent to crude drug 2.5g) successive administration 26 Week, each group rat general state, dietary amount, body weight, hematology indices, hepatic and renal function biochemical analysis, main organs index It is showed no exception；Pathologic diagnosis, administration group rat is by inspection organ with control group also without significant difference.It was discontinued by 2 weeks extensive After multiple, indices are compared with control group without obvious difference.
To sum up think, rheumatism 25-component safe range is big, toxicity will not be caused according to clinical dosage administration, while Retardance toxicity is not caused yet.
Shown by above-mentioned result of the test, the rheumatism 25-component ball items quality index after process modification more meets pharmacopeia Regulation, the content (Determination of Gardenoside) for especially leaching time and active ingredient has obtained beneficial improvement so that product of the present invention Steady quality, drug effect can be played steadily in the long term；Secondly the rheumatism 25-component ball after process modification is in security, stability side Face is also fully consistent with the relevant regulations of pharmacopeia.

Claims (10)

1. a kind of rheumatism 25-component ball, it contains following component,
2. rheumatism 25-component ball as claimed in claim 1, wherein resina liquidamberis is used as medicine after low-temperature treatment, the product for being obtained With preferably leaching the time limit.
3. rheumatism 25-component ball as claimed in claim 1 or 2, wherein donkey blood meal use different particle diameters, and particle size is not Same blood meal causes that the water-bindered pill is internally formed many irregular capillaries and hole, moisture when these holes are conducive to pill to dry Discharge suitable from inside to outside.
4. the rheumatism 25-component ball as described in claim any one of 1-3, drinks after wherein santal, santal are first crushed with kuh-seng Piece is inserted in pulverizer in batch (-type) filler mode and crushed, the fine powder after crushing again with other medicinal material mixing pills, the water-bindered pill Internal voids degree is obviously improved.
5. a kind of preparation method for preparing rheumatism 25-component ball described in claim 1, including resina liquidamberis through low-temperature treatment After be used as medicine, the product for being obtained have preferably leach the time limit.
6. preparation method as claimed in claim 5, the method wherein further includes step of the donkey blood meal using different particle diameters Suddenly, the different blood meal of particle size causes that the water-bindered pill is internally formed many irregular capillaries and hole, and these holes are conducive to Moisture discharge suitable from inside to outside when pill is dried.
7. preparation method as claimed in claim 6, drinks after the method further includes first to crush santal, santal with kuh-seng Piece inserts the step of being crushed in pulverizer in batch (-type) filler mode, and the fine powder after crushing mixes system with other medicinal materials again Ball, water-bindered pill internal voids degree is obviously improved.
8. qi-regulating is carried out as follows, the purposes in stasis of blood treatment patient's illnesses medicine is dissipated, described formula is as follows：
9. purposes as claimed in claim 8, wherein medicine resina liquidamberis in preparation process is used as medicine after low-temperature treatment, institute The product of acquisition have preferably leach the time limit.
10. purposes as claimed in claim 9, wherein donkey blood meal use different particle diameters, the different blood meal of particle size to cause The water-bindered pill is internally formed many irregular capillaries and hole, and moisture is suitable from inside to outside when these holes are conducive to pill to dry Discharge, and further by santal, santal first crush after insert in pulverizer in batch (-type) filler mode with kuh-seng medicine materical crude slice Row is crushed, fine powder after crushing again with other medicinal material mixing pills, this causes that water-bindered pill internal voids degree is obviously improved.
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